NALFON- fenoprofen calcium capsule

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

FENOPROFEN CALCIUM (UNII: 0X2CW1QABJ) (FENOPROFEN - UNII:RA33EAC7KY)

Disponível em:

Xspire Pharma

DCI (Denominação Comum Internacional):

FENOPROFEN CALCIUM

Composição:

FENOPROFEN 200 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

NALFON is indicated for: - Relief of mild to moderate pain in adults. - Relief of the signs and symptoms of rheumatoid arthrites. - Relief of the signs and symptoms of osteoarthritis. NALFON is contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to fenoprofen or any components of the drug product [ see Warnings and Precautions ( 5.7, 5.9) ] - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [ see Warnings and Precautions ( 5.7, 5.8) ] - In the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions ( 5.1) ] Risk Summary Use of NSAIDs, including NALFON, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some case

Resumo do produto:

NALFON ® (fenoprofen calcium, USP) are available in capsule form for oral administration, and are supplied as following: Storage: Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Preserve in well-closed containers.

Status de autorização:

New Drug Application

Folheto informativo - Bula

NALFON- FENOPROFEN CALCIUM CAPSULE
Xspire Pharma
----------
MEDICATION GUIDE FOR NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
What is the most important information I should know about medicines
called Nonsteroidal
Antiinflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
•
Increased risk of a heart attack or stroke that can lead to death.This
risk may happen early in
treatment and may increase:
•
with increasing doses of NSAIDs
•
with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass graft (CABG)."
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You may
have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack
•
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
•
anytime during use
•
without warning symptoms
•
that may cause death
The risk of getting an ulcer or bleeding increases with:
•
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
•
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
bleeding problems
NSAIDs should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat
(inflammation) from medical conditions
such as different types of arthritis, menstrual cramps, and other
types of short-term pain.
Who should not take NSAIDs?
Do not take NSAIDs:
•
if you have had an asthma attack, hives, or other allergic reaction
with aspirin or any other
NSAIDs
•
right before or after heart bypass surgery.
Before taking NSAIDS, tell your healthcare provider about

Características técnicas

NALFON- FENOPROFEN CALCIUM CAPSULE
XSPIRE PHARMA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NALFON SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NALFON.
NALFON (FENOPROFEN CALCIUM, USP) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1982
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) CAUSE AN INCREASED RISK
OF SERIOUS
CARDIOVASCULAR THROMBOTIC EVENTS, INCLUDING MYOCARDIAL INFARCTION AND
STROKE, WHICH
CAN BE FATAL. THIS RISK MAY OCCUR EARLY IN TREATMENT AND MAY INCREASE
WITH DURATION
OF USE. ( 5.1)
NALFON IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS
GRAFT (CABG)
SURGERY ( 4, 5.1)
NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI)
ADVERSE EVENTS
INCLUDING BLEEDING, ULCERATION, AND PERFORATION OF STOMACH OR
INTESTINES, WHICH CAN
BE FATAL. THESE EVENTS CAN OCCUR AT ANY TIME DURING USE AND WITHOUT
WARNING
SYMPTOMS. ELDERLY PATIENTS AND PATIENTS WITH A PRIOR HISTORY OF PEPTIC
ULCER DISEASE
AND/OR GI BLEEDING ARE AT GREATER RISK FOR SERIOUS GI EVENTS ( 5.2)
RECENT MAJOR CHANGES
Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic
Symptoms
(DRESS) ( 5.10)
04/2021
Warnings and Precautions, Fetal Toxicity ( 5.11)
04/2021
INDICATIONS AND USAGE
NALFON is a nonsteroidal anti-inflammatory drug indicated for:
Relief of mild to moderate pain in adults. ( 1)
Relief of the signs and symptoms of rheumatoid arthritis. ( 1)
Relief of the signs and symptoms of osteoarthritis. ( 1)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals
( 2.1)
Analgesia: For the treatment of mild to moderate pain, the recommended
dosage is 200 mg given
orally every 4 to 6 hours, as needed ( 2.1)
Rheumatoid Arthritis and Osteoarthritis: For the relief of signs and
symptoms of rheumatoid arthritis or
osteoarthritis the reco